The strong financial case for regenerative medicine and the regen industry.

Although the therapeutic promise of regenerative medicine is immensely exciting, the cost of product development, and particularly of clinical trials, for the more demanding applications will be high. For this reason it is vital for scientists and start-ups who wish to see their ideas implemented to be able to convince established major pharmaceutical or device companies with the necessary 'deep pockets' that the expenditure can yield an appropriate return. It also means that governments and health insurance companies must see a gain in funding regenerative medicine for patients. To address this issue the costs of five major medical conditions that could benefit from regenerative medicine have been defined for the USA as an illustration. This choice of country was made as potentially the largest initial market and one where the billing system for healthcare allows access to individual direct and some indirect costs. The data are complemented by a number of relevant examples of costs per quality-adjusted life year to indicate where current treatment methods are weak or strong. Finally, the relationship of the nascent regen* industry to the pharma and medical device sectors is summarized to assess the challenge of encouraging their involvement.